Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension

NCT07538388 | Not Yet Recruiting

• 1 other identifier: 2025-101645-BO-ff
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 4

Brief Summary

INDUCT-Multi is a multicenter randomized trial investigating whether continuous, compared to bolus, administration of norepinephrine during induction of general anesthesia reduces postinduction hypotension in high-risk non-cardiac surgery patients.

Conditions

Postinduction Hypotension

Keywords

postinduction hypotension; non-cardiac surgery; norepinephrine; bolus; hypotension; continuous

Outcome Measures

Primary Outcomes (1)

• Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min) (continuous endpoint)

  First 15 minutes after starting induction of general anesthesia

Secondary Outcomes (32)

• Area under a MAP of 60 mmHg (mmHg x min) (continuous endpoint)

  First 15 minutes after starting induction of general anesthesia

• Area under a MAP of 50 mmHg (mmHg x min) (continuous endpoint)

  First 15 minutes after starting induction of general anesthesia

• Area under a MAP of 40 mmHg (mmHg x min) (continuous endpoint)

  First 15 minutes after starting induction of general anesthesia

• Area above a MAP of 100 mmHg (mmHg x min) (continuous endpoint)

  First 15 minutes after starting induction of general anesthesia

• Area above a MAP of 110 mmHg (mmHg x min) (continuous endpoint)

  First 15 minutes after starting induction of general anesthesia

Other Outcomes (1)

• Acute kidney injury (binary endpoint)

  Within the first 3 postoperative days

Study Arms (2)

Continuous Norepinephrine Administration

EXPERIMENTAL

In patients assigned to continuous norepinephrine administration, norepinephrine will be administered continuously via a syringe infusion pump.

Procedure: Continuous Norepinephrine Administration

Bolus Norepinephrine Administration

NO INTERVENTION

In patients assigned to manual bolus norepinephrine administration, norepinephrine will be given manually in bolus doses.

Interventions

Continuous Norepinephrine Administration PROCEDURE

In patients assigned to continuous administration of norepinephrine, a syringe infusion pump will be prepared and connected to a peripheral or central venous catheter. The responsible anesthesiologist will start the norepinephrine infusion and adjust the infusion rate as necessary and may administer additional norepinephrine boluses via the syringe infusion pump if required.

Continuous Norepinephrine Administration

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We will include consenting patients ≥45 years scheduled for elective major non-cardiac surgery under general anesthesia with planned continuous intra-arterial blood pressure monitoring with a radial arterial catheter and with at least two of the following risk criteria for developing acute kidney injury:
• Age ≥65 years
• ASA physical status III or IV
• Chronic arterial hypertension
• Diabetes mellitus requiring medication
• Intra-abdominal surgery
• Preoperative renal insufficiency (serum creatinine ≥1.2 mg/dL)

You may not qualify if:

• Pregnancy
• Cardiac arrhythmia
• History of intracranial hemorrhage or intracranial aneurysm
• Clinical indication for continuous norepinephrine infusion during induction of general anesthesia (e.g., severe aortic valve stenosis, coronary artery disease, or heart failure)
• Patients who are unable to understand, read, and provide informed consent in German

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (4)

Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf

Düsseldorf, Germany

Location

Department of Anaesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Giessen, Justus-Liebig University Giessen

Giessen, Germany

Location

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

Department of Anaesthesiology, University Hospital LMU Munich

München, Germany

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kristen K Thomsen, MD

CONTACT

+4940741070215; kr.thomsen@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)